Section 203.34 - Policies and procedures; administrative systemsEach manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for the following:
(a) Distributing drug samples by mail or common carrier, including methodology for reconciliation of requests and receipts;(b) Distributing drug samples by means other than mail or common carrier including the methodology for:(1) Reconciling requests and receipts, identifying patterns of nonresponse, and the manufacturer's or distributor's response when such patterns are found;(2) Conducting the annual physical inventory and preparation of the reconciliation report;(3) Implementing a sample distribution security and audit system, including conducting random and for-cause audits of sales representatives by personnel independent of the sales force; and(4) Storage of drug samples by representatives;(c) Identifying any significant loss of drug samples and notifying FDA of the loss; and(d) Monitoring any loss or theft of drug samples.